BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1757754 · Received June 22, 2010

    Report

    Report Number
    2021710-2010-00028
    Event Type
    Malfunction
    Date Received
    June 22, 2010
    Date of Event
    January 26, 2010
    Report Date
    June 22, 2010
    Manufacturer
    CAREFUSION INC.
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ORIGINALLY DETERMINED TO BE NON-REPORTABLE ON 01/28/2010. ON 06/02/2010, WE RECEIVED A USER FACILITY MEDWATCH REPORT FROM THE USER FACILITY CONCERNING THIS EVENT. BASED ON THAT MEDWATCH REPORT, WE HAVE REVERSED THAT DECISION AND THUS WE WILL SUBMIT A MEDWATCH REPORT FOR THIS EVENT TO THE FDA. THE USER FACILITY DID NOT PROVIDE ANY PT OR DEVICE CODES ON THEIR USER FACILITY REPORT. CODES WERE DERIVED BASED ON THE INFO PROVIDED BY THE USER FACILITY IN THE USER FACILITY MEDWATCH REPORT AND INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION SERVICE DEPT TECH. THE CAREFUSION SERVICE DEPT. TECH EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY (LEAKING) PR4 REGULATOR. THE CAREFUSION SERVICE DEPT. TECH REPLACED THE PR4 REGULATOR, PERFORMED THE REQUIRED UPDATES, AND PERFORMED BOTH THE 8000 HOUR (OVERHAUL) AND 7 YEAR PREVENTATIVE MAINTENANCE (PM) SERVICES ON THE DEVICE WHICH INCLUDED A COMPLETE CALIBRATION AND CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS. ONCE COMPLETED THE DEVICE WAS PLACED INTO REFURBISHED STOCK READY TO BE SOLD AS A REFURBISHED DEVICE. THE PR4 REGULATOR WAS REPLACED AS A PART OF THE 8000 HOUR (OVERHAUL) PREVENTATIVE MAINTENANCE (PM) SERVICE PERFORMED ON THE UNIT. BASED ON THE AGE OF THE DEVICE (8 YEARS), THE FAILURE OF THE PR4 REGULATOR WAS MOST LIKELY DUE TO WORN INTERNAL COMPONENTS. ADDITIONAL INFO FROM THE VOLUNTARY REPORT: PT IDENTIFIER: (B)(6), DATE OF THE REPORT: 04/30/2010, COMMON DEVICE NAME: HIGH FREQUENCY OSCILLATOR, CONTACT NAME: (B)(4). HEALTH PROFESSIONAL: YES, OCCUPATION - RN. THE REPORTER DOES WANT THEIR IDENTITY DISCLOSED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REPRESENTATIVE. "[NAME REMOVED] CALLED TO FIND OUT IF THERE WAS GOING TO BE FREIGHT CHARGES ON THIS UNIT THAT WAS PICKED UP LAST NIGHT FOR PROBLEMS WHILE ON A PT. ACCORDING TO THE CUSTOMER, SHE HAD CALLED AND SPOKE TO [NAME REMOVED] ABOUT THE DELTA P DROPPING DOWN WHILE ON A PT FROM 90 TO 30. [NAME REMOVED] HAD THEM CHANGE OUT THE CIRCUIT AND CAP/DIAPHRAGMS WITH NO CHANGE. AFTER THEY HAD CHANGED THE BELLOWS/WATERTRAP, THE DELTA P WENT BACK UP FOR 30 MINUTES BUT THEN DROPPED BACK DOWN AGAIN. THE PT BEGAN TO REQUIRE INCREASED OXYGEN DURING AND AFTER THIS INCIDENT. THE UNIT WAS REPLACED, CHECKED RECORDS AND TECH SUPPORT WAS NOT NOTIFIED OF THE REPLACEMENT OR WHAT HAD HAPPENED WITH THE PT. TALKED WITH [NAME REMOVED] TO CONFIRM SOME THINGS, SHE STATED THAT THERE WAS NO WATER IN THE AIRWAY SENSE LINE AND THAT THE PT DID HAVE 3 CHEST TUBES, BUT SINCE THE DELTA P HAD DROPPED, THE MAP WAS STABLE THROUGHOUT THE INCIDENT. TOLD CUSTOMER THAT FREIGHT CHARGES WILL NOT BE CHARGED TO THEM. DETERMINED AFTER S/N WAS GIVEN THAT UNIT HAS BEEN ONSITE SINCE 9/08. AFTER THE NEW UNIT WAS PUT ON THE PT, THE SETTINGS WERE STABLE AND THE PT SETTINGS WERE WEANED DOWN AND THERE WAS SOME IMPROVEMENT. WILL FOLLOW UP WITH HILL-ROM." THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CAREFUSION FROM THE USER FACILITY ON 06/02/2010. "PT ON HIGH FREQUENCY OSCILLATION VENTILATOR. THERAPIST NOTED PT SATURATION DROPPING TO 88 - 90%. THERAPIST NOTED AMPLITUDE LEVEL DROPPED BELOW 70 - 30. REMOVED VENT AND BAGGED WITH 100% OXYGEN WITH PEEP VALVE. THERAPIST CHECKED FOR LEAKS AND MACHINE PASSED PERFORMANCE TEST. PLACED BACK ON VENT. AMPLITUDE AGAIN CHANGED AND VENT WAS CHANGED OUT TO AVOID PT COMPROMISE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS VENTILATOR, HIGH FREQUENCY/LSZ LSZ CAREFUSION INC. 3100B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention (B)(4).